NCT01011920 · ADVERSE EVENTS

Adverse events

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma · Source last updated 2026-03-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
Other-event reporting threshold: 5%

All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A / MTX + AraC Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses	39 / 75	75 / 75	56 / 75
Arm B / MTX + Ara-C + Rituximab Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles	38 / 69	68 / 69	41 / 69
Arm C / MTX + Ara-C + Rituximab+Thiotepa Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4	39 / 75	74 / 75	33 / 75
Arm D / WBRT 36 Gy +/- Boost 9 Gy ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.	5 / 55	38 / 55	30 / 55
Arm E / BCNU + Thiotepa + APBSCT Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0 Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)	10 / 58	49 / 58	23 / 58

Group identifiers: EG000: Arm A / MTX + AraC · EG001: Arm B / MTX + Ara-C + Rituximab · EG002: Arm C / MTX + Ara-C + Rituximab+Thiotepa · EG003: Arm D / WBRT 36 Gy +/- Boost 9 Gy · EG004: Arm E / BCNU + Thiotepa + APBSCT

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Peripheral arterial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Hemorrhage, CNS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
1
num At Risk
58
num Events
1
term
Hemorrhage Pulmonary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
6
num At Risk
75
num Events
6
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
4
num At Risk
75
num Events
4
group Id
EG003
num Affected
1
num At Risk
55
num Events
1
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
2
num At Risk
69
num Events
2
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Pain general
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
2
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Pain abdomen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
1
num At Risk
75
num Events
2
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Lower extremity gait
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Mulri-organ failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
9
num At Risk
75
num Events
16
group Id
EG001
num Affected
11
num At Risk
69
num Events
18
group Id
EG002
num Affected
7
num At Risk
75
num Events
11
group Id
EG003
num Affected
5
num At Risk
55
num Events
5
group Id
EG004
num Affected
7
num At Risk
58
num Events
7
term
Coagulation disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
34
group Id
EG001
num Affected
18
num At Risk
69
num Events
38
group Id
EG002
num Affected
13
num At Risk
75
num Events
27
group Id
EG003
num Affected
10
num At Risk
55
num Events
10
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Neurological toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
66
num At Risk
75
num Events
187
group Id
EG001
num Affected
65
num At Risk
69
num Events
207
group Id
EG002
num Affected
71
num At Risk
75
num Events
261
group Id
EG003
num Affected
9
num At Risk
55
num Events
9
group Id
EG004
num Affected
40
num At Risk
58
num Events
40
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
68
num At Risk
75
num Events
129
group Id
EG001
num Affected
65
num At Risk
69
num Events
158
group Id
EG002
num Affected
69
num At Risk
75
num Events
198
group Id
EG003
num Affected
7
num At Risk
55
num Events
7
group Id
EG004
num Affected
49
num At Risk
58
num Events
58
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
67
num At Risk
75
num Events
177
group Id
EG001
num Affected
65
num At Risk
69
num Events
203
group Id
EG002
num Affected
70
num At Risk
75
num Events
248
group Id
EG003
num Affected
2
num At Risk
55
num Events
2
group Id
EG004
num Affected
49
num At Risk
58
num Events
58
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
75
num Events
5
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
6
num At Risk
55
num Events
6
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
3
num At Risk
75
num Events
6
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
2
num At Risk
69
num Events
6
group Id
EG002
num Affected
7
num At Risk
75
num Events
10
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
4
num At Risk
55
num Events
4
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Hearing impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
16
group Id
EG001
num Affected
22
num At Risk
69
num Events
44
group Id
EG002
num Affected
30
num At Risk
75
num Events
30
group Id
EG003
num Affected
1
num At Risk
55
num Events
1
group Id
EG004
num Affected
19
num At Risk
58
num Events
19
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
20
group Id
EG001
num Affected
29
num At Risk
69
num Events
68
group Id
EG002
num Affected
30
num At Risk
75
num Events
61
group Id
EG003
num Affected
7
num At Risk
55
num Events
7
group Id
EG004
num Affected
16
num At Risk
58
num Events
16
term
Nausea/Vomiting

Complete source fields

description

event Groups

deaths Num Affected
56
deaths Num At Risk
75
description
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
id
EG000
other Num Affected
75
other Num At Risk
75
serious Num Affected
39
serious Num At Risk
75
title
Arm A / MTX + AraC
deaths Num Affected
41
deaths Num At Risk
69
description
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
id
EG001
other Num Affected
68
other Num At Risk
69
serious Num Affected
38
serious Num At Risk
69
title
Arm B / MTX + Ara-C + Rituximab
deaths Num Affected
33
deaths Num At Risk
75
description
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
id
EG002
other Num Affected
74
other Num At Risk
75
serious Num Affected
39
serious Num At Risk
75
title
Arm C / MTX + Ara-C + Rituximab+Thiotepa
deaths Num Affected
30
deaths Num At Risk
55
description
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
id
EG003
other Num Affected
38
other Num At Risk
55
serious Num Affected
5
serious Num At Risk
55
title
Arm D / WBRT 36 Gy +/- Boost 9 Gy
deaths Num Affected
23
deaths Num At Risk
58
description
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0 Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
id
EG004
other Num Affected
49
other Num At Risk
58
serious Num Affected
10
serious Num At Risk
58
title
Arm E / BCNU + Thiotepa + APBSCT

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
9
num At Risk
75
num Events
16
group Id
EG001
num Affected
11
num At Risk
69
num Events
18
group Id
EG002
num Affected
7
num At Risk
75
num Events
11
group Id
EG003
num Affected
5
num At Risk
55
num Events
5
group Id
EG004
num Affected
7
num At Risk
58
num Events
7
term
Coagulation disorders
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
34
group Id
EG001
num Affected
18
num At Risk
69
num Events
38
group Id
EG002
num Affected
13
num At Risk
75
num Events
27
group Id
EG003
num Affected
10
num At Risk
55
num Events
10
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Neurological toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
66
num At Risk
75
num Events
187
group Id
EG001
num Affected
65
num At Risk
69
num Events
207
group Id
EG002
num Affected
71
num At Risk
75
num Events
261
group Id
EG003
num Affected
9
num At Risk
55
num Events
9
group Id
EG004
num Affected
40
num At Risk
58
num Events
40
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
68
num At Risk
75
num Events
129
group Id
EG001
num Affected
65
num At Risk
69
num Events
158
group Id
EG002
num Affected
69
num At Risk
75
num Events
198
group Id
EG003
num Affected
7
num At Risk
55
num Events
7
group Id
EG004
num Affected
49
num At Risk
58
num Events
58
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
67
num At Risk
75
num Events
177
group Id
EG001
num Affected
65
num At Risk
69
num Events
203
group Id
EG002
num Affected
70
num At Risk
75
num Events
248
group Id
EG003
num Affected
2
num At Risk
55
num Events
2
group Id
EG004
num Affected
49
num At Risk
58
num Events
58
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
75
num Events
5
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
6
num At Risk
55
num Events
6
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
3
num At Risk
75
num Events
6
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
4
num At Risk
58
num Events
4
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
2
num At Risk
69
num Events
6
group Id
EG002
num Affected
7
num At Risk
75
num Events
10
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
4
num At Risk
55
num Events
4
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Hearing impairment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
16
group Id
EG001
num Affected
22
num At Risk
69
num Events
44
group Id
EG002
num Affected
30
num At Risk
75
num Events
30
group Id
EG003
num Affected
1
num At Risk
55
num Events
1
group Id
EG004
num Affected
19
num At Risk
58
num Events
19
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
13
num At Risk
75
num Events
20
group Id
EG001
num Affected
29
num At Risk
69
num Events
68
group Id
EG002
num Affected
30
num At Risk
75
num Events
61
group Id
EG003
num Affected
7
num At Risk
55
num Events
7
group Id
EG004
num Affected
16
num At Risk
58
num Events
16
term
Nausea/Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
75
num Events
1
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Peripheral arterial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Hemorrhage, CNS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
1
num At Risk
58
num Events
1
term
Hemorrhage Pulmonary
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
6
num At Risk
75
num Events
6
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
4
num At Risk
75
num Events
4
group Id
EG003
num Affected
1
num At Risk
55
num Events
1
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
2
num At Risk
69
num Events
2
group Id
EG002
num Affected
1
num At Risk
75
num Events
1
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Pain general
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
2
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Pain abdomen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
0
num At Risk
69
num Events
0
group Id
EG002
num Affected
1
num At Risk
75
num Events
2
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Lower extremity gait
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
75
num Events
0
group Id
EG001
num Affected
1
num At Risk
69
num Events
1
group Id
EG002
num Affected
0
num At Risk
75
num Events
0
group Id
EG003
num Affected
0
num At Risk
55
num Events
0
group Id
EG004
num Affected
0
num At Risk
58
num Events
0
term
Mulri-organ failure

time Frame

The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice