NCT00701103 · ADVERSE EVENTS

Adverse events

Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001) · Source last updated 2018-08-08

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: Up to 30 days after last dose of study drug (Up to 25 months)
Other-event reporting threshold: 5%

The population consisted of all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.	0 / 5	5 / 5	Not reported / Not reported
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.	0 / 3	3 / 3	Not reported / Not reported
Dalotuzumab 5 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.	2 / 8	6 / 8	Not reported / Not reported
Dalotuzumab 10 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.	2 / 6	5 / 6	Not reported / Not reported
Dalotuzumab 10 mg/kg Q1W (20 mg/mL) Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.	2 / 6	4 / 6	Not reported / Not reported
Dalotuzumab 15 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.	3 / 6	5 / 6	Not reported / Not reported
Dalotuzumab 15 mg/kg Q1W (20 mg/mL) Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.	3 / 8	8 / 8	Not reported / Not reported
Dalotuzumab 20 mg/kg Q1W (10 mg/mL) Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.	0 / 7	6 / 7	Not reported / Not reported
Dalotuzumab 20 mg/kg Q1W (20 mg/mL) Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.	2 / 9	8 / 9	Not reported / Not reported
Dalotuzumab 20 mg/kg Q2W (20 mg/mL) Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.	3 / 11	9 / 11	Not reported / Not reported
Dalotuzumab 30 mg/kg Q3W (20 mg/mL) Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.	1 / 11	11 / 11	Not reported / Not reported

Group identifiers: EG000: Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) · EG001: Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) · EG002: Dalotuzumab 5 mg/kg Q1W (10 mg/mL) · EG003: Dalotuzumab 10 mg/kg Q1W (10 mg/mL) · EG004: Dalotuzumab 10 mg/kg Q1W (20 mg/mL) · EG005: Dalotuzumab 15 mg/kg Q1W (10 mg/mL) · EG006: Dalotuzumab 15 mg/kg Q1W (20 mg/mL) · EG007: Dalotuzumab 20 mg/kg Q1W (10 mg/mL) · EG008: Dalotuzumab 20 mg/kg Q1W (20 mg/mL) · EG009: Dalotuzumab 20 mg/kg Q2W (20 mg/mL) · EG010: Dalotuzumab 30 mg/kg Q3W (20 mg/mL)

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
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
8
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Skin bacterial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Colon cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Ewing's sarcoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Convulsion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Spinal cord compression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Renal failure acute

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
6
num Events
4
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
8
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
2
num At Risk
7
num Events
3
group Id
EG008
num Affected
1
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
8
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
8
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
2
num At Risk
8
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
2
num At Risk
11
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
2
num At Risk
11
num Events
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
2
num At Risk
11
num Events
2
term
Dyspepsia

Complete source fields

description

The population consisted of all participants who received at least one dose of study drug.

event Groups

description
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG002
other Num Affected
6
other Num At Risk
8
serious Num Affected
2
serious Num At Risk
8
title
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG003
other Num Affected
5
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
id
EG004
other Num Affected
4
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
description
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG005
other Num Affected
5
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
id
EG006
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
description
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
id
EG007
other Num Affected
6
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
description
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
id
EG008
other Num Affected
8
other Num At Risk
9
serious Num Affected
2
serious Num At Risk
9
title
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
description
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
id
EG009
other Num Affected
9
other Num At Risk
11
serious Num Affected
3
serious Num At Risk
11
title
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
description
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
id
EG010
other Num Affected
11
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
6
num Events
4
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
8
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
2
num At Risk
6
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
2
num At Risk
7
num Events
3
group Id
EG008
num Affected
1
num At Risk
9
num Events
2
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
8
num Events
2
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
8
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
2
num At Risk
8
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
2
num At Risk
11
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
2
num At Risk
11
num Events
4
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
2
num At Risk
11
num Events
2
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
9
num Events
1
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
8
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Skin bacterial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
1
num At Risk
11
num Events
1
term
Femur fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Colon cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Ewing's sarcoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Tumour pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Convulsion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
0
num At Risk
11
num Events
0
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Spinal cord compression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
8
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
9
num Events
0
group Id
EG009
num Affected
1
num At Risk
11
num Events
1
group Id
EG010
num Affected
0
num At Risk
11
num Events
0
term
Renal failure acute

time Frame

Up to 30 days after last dose of study drug (Up to 25 months)

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

Preserved source evidence · Not medical advice