Trial Outcomes & Findings for Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma (NCT NCT00134030)
NCT ID: NCT00134030
Last Updated: 2023-06-07
Results Overview
EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy. EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1334 participants
Primary outcome timeframe
From date of randomization to date of the event.
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
MAP-GR
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
359
|
357
|
310
|
308
|
|
Overall Study
COMPLETED
|
359
|
357
|
310
|
308
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma
Baseline characteristics by cohort
| Measure |
MAP-GR
n=359 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
n=357 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
n=310 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
n=308 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
Total
n=1334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14 years
n=99 Participants
|
14 years
n=107 Participants
|
15 years
n=206 Participants
|
15 years
n=7 Participants
|
14 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
117 Participants
n=7 Participants
|
548 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
191 Participants
n=7 Participants
|
786 Participants
n=31 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=99 Participants
|
9 participants
n=107 Participants
|
7 participants
n=206 Participants
|
11 participants
n=7 Participants
|
47 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=99 Participants
|
134 participants
n=107 Participants
|
142 participants
n=206 Participants
|
139 participants
n=7 Participants
|
543 participants
n=31 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
5 participants
n=7 Participants
|
13 participants
n=31 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=7 Participants
|
25 participants
n=31 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
8 participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
9 participants
n=206 Participants
|
7 participants
n=7 Participants
|
44 participants
n=31 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
6 participants
n=31 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
12 participants
n=31 Participants
|
|
Region of Enrollment
Finland
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
85 participants
n=99 Participants
|
90 participants
n=107 Participants
|
60 participants
n=206 Participants
|
63 participants
n=7 Participants
|
298 participants
n=31 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
3 participants
n=7 Participants
|
19 participants
n=31 Participants
|
|
Region of Enrollment
Ireland
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Region of Enrollment
Netherlands
|
21 participants
n=99 Participants
|
18 participants
n=107 Participants
|
16 participants
n=206 Participants
|
10 participants
n=7 Participants
|
65 participants
n=31 Participants
|
|
Region of Enrollment
Norway
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
12 participants
n=206 Participants
|
5 participants
n=7 Participants
|
34 participants
n=31 Participants
|
|
Region of Enrollment
Sweden
|
14 participants
n=99 Participants
|
10 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
47 participants
n=99 Participants
|
47 participants
n=107 Participants
|
33 participants
n=206 Participants
|
39 participants
n=7 Participants
|
166 participants
n=31 Participants
|
|
Site of tumour
Femur
|
179 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
166 Participants
n=7 Participants
|
690 Participants
n=31 Participants
|
|
Site of tumour
Tibia
|
113 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
366 Participants
n=31 Participants
|
|
Site of tumour
Fibula
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
|
Site of tumour
Humerus
|
36 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
135 Participants
n=31 Participants
|
|
Site of tumour
Radius
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Site of tumour
Ulna
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Site of tumour
Scapula/clavicle
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Site of tumour
Pelvis/sacrum
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Site of tumour
Rib
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Site of tumour
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Location of tumour on the bone
Proximal
|
156 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
529 Participants
n=31 Participants
|
|
Location of tumour on the bone
Diapysis
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Location of tumour on the bone
Distal
|
180 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
168 Participants
n=7 Participants
|
703 Participants
n=31 Participants
|
|
Location of tumour on the bone
N/A (not long bone)
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Pathological fracture at diagnosis
No
|
321 Participants
n=99 Participants
|
308 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
270 Participants
n=7 Participants
|
1175 Participants
n=31 Participants
|
|
Pathological fracture at diagnosis
Yes
|
37 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
155 Participants
n=31 Participants
|
|
Pathological fracture at diagnosis
Data missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Lung metastases
No/possible
|
324 Participants
n=99 Participants
|
321 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
280 Participants
n=7 Participants
|
1197 Participants
n=31 Participants
|
|
Lung metastases
Yes
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
137 Participants
n=31 Participants
|
|
Histological classification
Conventional
|
320 Participants
n=99 Participants
|
322 Participants
n=107 Participants
|
288 Participants
n=206 Participants
|
289 Participants
n=7 Participants
|
1219 Participants
n=31 Participants
|
|
Histological classification
Telangiectatic
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
62 Participants
n=31 Participants
|
|
Histological classification
Small cell
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Histological classification
High-grade surface
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Histological classification
Other
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Histological classification
Data missing
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of the event.EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy. EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary.
Outcome measures
| Measure |
MAP-GR
n=359 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
n=357 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
n=310 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
n=308 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
|---|---|---|---|---|
|
Event-free Survival (EFS)
|
74 Percentage EFS
Interval 69.0 to 79.0
|
77 Percentage EFS
Interval 72.0 to 81.0
|
55 Percentage EFS
Interval 49.0 to 60.0
|
53 Percentage EFS
Interval 47.0 to 59.0
|
SECONDARY outcome
Timeframe: From date of randomization to date of death.Overall survival is time from randomization until death from any cause. Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Participants will be assessed for up to 10 years. 5 year overall survival is provided as a summary.
Outcome measures
| Measure |
MAP-GR
n=359 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
n=357 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
n=310 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
n=308 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
|---|---|---|---|---|
|
Percentage of Patients With Overall Survival
|
84 Percentage of participants
Interval 80.0 to 88.0
|
84 Percentage of participants
Interval 81.0 to 88.0
|
68 Percentage of participants
Interval 63.0 to 73.0
|
68 Percentage of participants
Interval 63.0 to 73.0
|
SECONDARY outcome
Timeframe: Adverse events are assessed for up to 10 years per participant.Population: Adverse events are only analyzed in participants who started treatment and for whom toxicity data were provided.
Percentages of patients experiencing grade 3 and 4 adverse events. These will be compared using chi-square tests or Fisher's exact tests where appropriate.
Outcome measures
| Measure |
MAP-GR
n=356 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
n=355 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
n=301 Participants
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
n=298 Participants
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
|---|---|---|---|---|
|
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
348 Participants
|
340 Participants
|
287 Participants
|
281 Participants
|
Adverse Events
MAP-GR
Serious events: 49 serious events
Other events: 0 other events
Deaths: 0 deaths
MAPifn
Serious events: 76 serious events
Other events: 0 other events
Deaths: 0 deaths
MAP-PR
Serious events: 36 serious events
Other events: 0 other events
Deaths: 0 deaths
MAPIE
Serious events: 43 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MAP-GR
n=359 participants at risk
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 17, 22, and 26 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 17. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 16, 20, 21, 24, 25, 28, and 29.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPifn
n=357 participants at risk
Patients receive doxorubicin, cisplatin, and high-dose MTX as in arm I. Patients than receive PEG-interferon alfa-2b subcutaneously once daily on day 1 in weeks 30-104.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Peginterferon Alfa-2b: Given subcutaneously
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAP-PR
n=310 participants at risk
Patients receive doxorubicin, cisplatin, and high-dose MTX as in group 1 arm I.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
MAPIE
n=308 participants at risk
Patients receive doxorubicin IV continuously over 48 hours on days 1-2 in weeks 12, 20, 28, and 36 and cisplatin IV over 4 hours on days 1 and 2 in weeks 12 and 28. Patients also receive high-dose MTX IV over 4 hours on day 1 in weeks 15, 19, 23, 27, 31, 35, 39, and 40. Patients receive ifosfamide IV over 4 hours on days 1-5 in weeks 16, 24, and 32 and on days 1-3 in weeks 20 and 36 and etoposide IV over 1 hour on days 1-5 in weeks 16, 24, and 32.
Cisplatin: Given IV
Doxorubicin Hydrochloride: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Methotrexate: Given IV
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Therapeutic Conventional Surgery: Undergo amputation or limb salvage surgery
|
|---|---|---|---|---|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.9%
7/359 • Number of events 11 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
1.4%
5/357 • Number of events 6 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.97%
3/310 • Number of events 4 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
3.2%
10/308 • Number of events 17 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
ATRIAL THROMBOSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/308 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Ear and labyrinth disorders
DEAFNESS BILATERAL
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Endocrine disorders
THYROIDITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
ANAL ULCER
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
NAUSEA
|
0.28%
1/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.84%
3/359 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
VOMITING
|
0.84%
3/359 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
CHILLS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
COMPLICATION ASSOCIATED WITH DEVICE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
IMPAIRED HEALING
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
INFUSION SITE THROMBOSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.84%
3/359 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
1.9%
6/310 • Number of events 7 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.97%
3/308 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
PYREXIA
|
1.1%
4/359 • Number of events 7 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.84%
3/357 • Number of events 5 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/308 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Hepatobiliary disorders
VENOOCCLUSIVE LIVER DISEASE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Immune system disorders
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
APPENDICITIS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.84%
3/359 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
1.7%
6/357 • Number of events 7 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.97%
3/310 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
DEVICE RELATED SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ECTHYMA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ERYSIPELAS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
H1N1 INFLUENZA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
IMPLANT SITE CELLULITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
INCISION SITE ABSCESS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
PNEUMONIA
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
SEPSIS
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
1.3%
4/308 • Number of events 4 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
STAPHYLOCOCCAL SCALDED SKIN SYNDROME
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
WOUND INFECTION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.84%
3/357 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
PERIPROSTHETIC FRACTURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE WOUND COMPLICATION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
CHEMOTHERAPEUTIC DRUG LEVEL INCREASED
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
DRUG CLEARANCE DECREASED
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
INFLUENZA B VIRUS TEST POSITIVE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 3 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/308 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EWING'S SARCOMA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA STAGE I
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
ANOSMIA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
CEREBRAL ARTERY EMBOLISM
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.56%
2/359 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
HEMIPARESIS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
HEMIPLEGIA
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
LEUKOENCEPHALOPATHY
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
SEIZURE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
STUPOR
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
TOXIC ENCEPHALOPATHY
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Product Issues
DEVICE FAILURE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Product Issues
THROMBOSIS IN DEVICE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Psychiatric disorders
MANIA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Renal and urinary disorders
NEPHROPATHY TOXIC
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.56%
2/357 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/308 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.28%
1/357 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Vascular disorders
PELVIC VENOUS THROMBOSIS
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Vascular disorders
PERIPHERAL ARTERY DISSECTION
|
0.28%
1/359 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/310 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Eye disorders
OPTIC NEUROPATHY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
General disorders
INFUSION SITE ERYTHEMA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
SEPTIC ARTHRITIS STAPHYLOCOCCAL
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Infections and infestations
VARICELLA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Musculoskeletal and connective tissue disorders
BONE INFARCTION
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
CYTOTOXIC OEDEMA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
MONOPARESIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.65%
2/310 • Number of events 2 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERSENSITIVITY PNEUMONITIS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/359 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/357 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.32%
1/310 • Number of events 1 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
0.00%
0/308 • From randomisation until 30 days after last protocol treatment up to 10 years.
The total number of participants represented in the Serious Adverse Events Table is 1,334 (MAP-GR +MAPifn +MAP-PR+MAPIE). On an intention to treat basis, this includes16 patients (across all arms) who did not start treatment or had no adverse event data available.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place