NCT01784068 · ADVERSE EVENTS

Adverse events

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients · Source last updated 2026-08-13

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: From first dose of nilotinib through up to approximately 11 years of study participation, including the NTCS phase (up to 52 weeks), TFR phase (up to 528 weeks), and NTRI phases (up to 500 weeks)
Other-event reporting threshold: 5%

Adverse Events are presented separately for the respective study phases.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NTCS Nilotinib treatment consolidation (NTCS) phase: During the first 52 weeks of the consolidation phase, all patients were treated with the planned dose of 300 mg nilotinib b.i.d. (or at a reduced dose level of 400 mg once daily if patients did not tolerate the planned dose). The treatment continued until the patient experienced unacceptable toxicity, disease progression, death, lost to follow-up and/or treatment was discontinued at the discretion of the Investigator or withdrawal of consent. In order for patients to be eligible for the TFR phase, they had to fulfill the protocol specific definition of durable MRD.	20 / 215	159 / 215	2 / 215
TFR Phase Nilotinib treatment-free remission (TFR) phase: Patients who fulfilled the protocol specific definition of durable MRD at the end of the NTCS phase were to suspend nilotinib therapy on the day they entered this phase.	34 / 190	136 / 190	2 / 190
NTRI Nilotinib treatment re-initiation (NTRI) phase: If a patient had a loss of MMR (BCR::ABL1 \> 0.1% IS) in the TFR phase, the patient restarted nilotinib treatment. Patients were on nilotinib treatment for up to 528 weeks after the last patient entered the nilotinib TFR phase.	40 / 91	86 / 91	5 / 91
NTCT Nilotinib treatment continuation (NTCT) phase: If a patient was ineligible to start the TFR phase, he/she continued the nilotinib treatment in the continuation phase (52 weeks).	1 / 13	11 / 13	0 / 13
TFR-2 Nilotinib treatment-free remission-2 (TFR-2) phase: Patients who fulfilled the protocol specific definition of durable MRD after the continuation phase (NTCT) were to suspend nilotinib therapy on the day they entered this phase. Duration of the TFR-2 phase and the BCR::ABL1 transcript level monitoring schedule was the same as that for the TFR phase. During the TFR-2 phase, the same rules in case of loss of MR4.0 or of MMR were applied as during the TFR phase.	1 / 10	7 / 10	0 / 10
NTRI-2 Nilotinib treatment re-initiation-2 (NTRI-2) phase: In the nilotinib TFR-2 phase, loss of MMR required nilotinib treatment re-initiation and patients were to enter NTRI-2 phase. The NTRI-2 phase was conducted in the same manner as the NTRI phase.	3 / 5	5 / 5	0 / 5
NTCT-P Nilotinib treatment prolonged continuation (NTCT - P) phase: Patients were eligible to enter the TFR-2 phase after the NTCT phase if they fulfilled the protocol-specific definition of durable MRD. Patients who did not qualify to start TFR-2 continued to receive nilotinib treatment in the NTCT-P phase for up to 528 weeks after the last patient entered the nilotinib TFR phase, or until the patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or the treatment was discontinued at the discretion of the Investigator or withdrawal of consent. The patients in the NTCT-P phase were followed for safety and efficacy (PCR data).	0 / 3	2 / 3	0 / 3
All Patients All the patients enrolled in the study	84 / 215	205 / 215	9 / 215

Group identifiers: EG000: NTCS · EG001: TFR Phase · EG002: NTRI · EG003: NTCT · EG004: TFR-2 · EG005: NTRI-2 · EG006: NTCT-P · EG007: All Patients

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
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
IRIS NEOVASCULARISATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ASCITES
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
GASTRIC ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
HAEMORRHOIDS

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
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
9
num At Risk
215
group Id
EG001
num Affected
6
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
15
num At Risk
215
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
12
num At Risk
215
group Id
EG001
num Affected
9
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
22
num At Risk
215
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
7
num At Risk
215
group Id
EG001
num Affected
2
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
10
num At Risk
215
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
6
num At Risk
215
group Id
EG001
num Affected
5
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
11
num At Risk
215
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
9
num At Risk
215
group Id
EG001
num Affected
6
num At Risk
190
group Id
EG002
num Affected
4
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
18
num At Risk
215
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
3
num At Risk
215
group Id
EG001
num Affected
2
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
6
num At Risk
215
term
INFLUENZA LIKE ILLNESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
LOCALISED OEDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
3
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
8
num At Risk
215
term
GASTROENTERITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
7
num At Risk
215
group Id
EG001
num Affected
4
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
11
num At Risk
215
term
INFLUENZA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
4
num At Risk
215
term
LARYNGITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
22
num At Risk
215
group Id
EG001
num Affected
17
num At Risk
190
group Id
EG002
num Affected
7
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
36
num At Risk
215
term
NASOPHARYNGITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
6
num At Risk
215
term
PHARYNGITIS

Complete source fields

description

Adverse Events are presented separately for the respective study phases.

event Groups

deaths Num Affected
2
deaths Num At Risk
215
description
Nilotinib treatment consolidation (NTCS) phase: During the first 52 weeks of the consolidation phase, all patients were treated with the planned dose of 300 mg nilotinib b.i.d. (or at a reduced dose level of 400 mg once daily if patients did not tolerate the planned dose). The treatment continued until the patient experienced unacceptable toxicity, disease progression, death, lost to follow-up and/or treatment was discontinued at the discretion of the Investigator or withdrawal of consent. In order for patients to be eligible for the TFR phase, they had to fulfill the protocol specific definition of durable MRD.
id
EG000
other Num Affected
159
other Num At Risk
215
serious Num Affected
20
serious Num At Risk
215
title
NTCS
deaths Num Affected
2
deaths Num At Risk
190
description
Nilotinib treatment-free remission (TFR) phase: Patients who fulfilled the protocol specific definition of durable MRD at the end of the NTCS phase were to suspend nilotinib therapy on the day they entered this phase.
id
EG001
other Num Affected
136
other Num At Risk
190
serious Num Affected
34
serious Num At Risk
190
title
TFR Phase
deaths Num Affected
5
deaths Num At Risk
91
description
Nilotinib treatment re-initiation (NTRI) phase: If a patient had a loss of MMR (BCR::ABL1 \> 0.1% IS) in the TFR phase, the patient restarted nilotinib treatment. Patients were on nilotinib treatment for up to 528 weeks after the last patient entered the nilotinib TFR phase.
id
EG002
other Num Affected
86
other Num At Risk
91
serious Num Affected
40
serious Num At Risk
91
title
NTRI
deaths Num Affected
0
deaths Num At Risk
13
description
Nilotinib treatment continuation (NTCT) phase: If a patient was ineligible to start the TFR phase, he/she continued the nilotinib treatment in the continuation phase (52 weeks).
id
EG003
other Num Affected
11
other Num At Risk
13
serious Num Affected
1
serious Num At Risk
13
title
NTCT
deaths Num Affected
0
deaths Num At Risk
10
description
Nilotinib treatment-free remission-2 (TFR-2) phase: Patients who fulfilled the protocol specific definition of durable MRD after the continuation phase (NTCT) were to suspend nilotinib therapy on the day they entered this phase. Duration of the TFR-2 phase and the BCR::ABL1 transcript level monitoring schedule was the same as that for the TFR phase. During the TFR-2 phase, the same rules in case of loss of MR4.0 or of MMR were applied as during the TFR phase.
id
EG004
other Num Affected
7
other Num At Risk
10
serious Num Affected
1
serious Num At Risk
10
title
TFR-2
deaths Num Affected
0
deaths Num At Risk
5
description
Nilotinib treatment re-initiation-2 (NTRI-2) phase: In the nilotinib TFR-2 phase, loss of MMR required nilotinib treatment re-initiation and patients were to enter NTRI-2 phase. The NTRI-2 phase was conducted in the same manner as the NTRI phase.
id
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
NTRI-2
deaths Num Affected
0
deaths Num At Risk
3
description
Nilotinib treatment prolonged continuation (NTCT - P) phase: Patients were eligible to enter the TFR-2 phase after the NTCT phase if they fulfilled the protocol-specific definition of durable MRD. Patients who did not qualify to start TFR-2 continued to receive nilotinib treatment in the NTCT-P phase for up to 528 weeks after the last patient entered the nilotinib TFR phase, or until the patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or the treatment was discontinued at the discretion of the Investigator or withdrawal of consent. The patients in the NTCT-P phase were followed for safety and efficacy (PCR data).
id
EG006
other Num Affected
2
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
NTCT-P
deaths Num Affected
9
deaths Num At Risk
215
description
All the patients enrolled in the study
id
EG007
other Num Affected
205
other Num At Risk
215
serious Num Affected
84
serious Num At Risk
215
title
All Patients

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
9
num At Risk
215
group Id
EG001
num Affected
6
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
15
num At Risk
215
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
12
num At Risk
215
group Id
EG001
num Affected
9
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
22
num At Risk
215
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
7
num At Risk
215
group Id
EG001
num Affected
2
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
10
num At Risk
215
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
6
num At Risk
215
group Id
EG001
num Affected
5
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
11
num At Risk
215
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
9
num At Risk
215
group Id
EG001
num Affected
6
num At Risk
190
group Id
EG002
num Affected
4
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
18
num At Risk
215
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
3
num At Risk
215
group Id
EG001
num Affected
2
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
6
num At Risk
215
term
INFLUENZA LIKE ILLNESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
LOCALISED OEDEMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
3
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
8
num At Risk
215
term
GASTROENTERITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
7
num At Risk
215
group Id
EG001
num Affected
4
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
11
num At Risk
215
term
INFLUENZA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
4
num At Risk
215
term
LARYNGITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
22
num At Risk
215
group Id
EG001
num Affected
17
num At Risk
190
group Id
EG002
num Affected
7
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
36
num At Risk
215
term
NASOPHARYNGITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
3
num At Risk
86
group Id
EG003
num Affected
1
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
6
num At Risk
215
term
PHARYNGITIS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ANGINA PECTORIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
CARDIAC ARREST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
CARDIAC FAILURE CONGESTIVE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
2
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
CORONARY ARTERY DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
1
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
2
num At Risk
215
term
MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
IRIS NEOVASCULARISATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
ASCITES
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
215
group Id
EG001
num Affected
0
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
GASTRIC ULCER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
215
group Id
EG001
num Affected
1
num At Risk
190
group Id
EG002
num Affected
0
num At Risk
86
group Id
EG003
num Affected
0
num At Risk
13
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
0
group Id
EG006
num Affected
0
num At Risk
2
group Id
EG007
num Affected
1
num At Risk
215
term
HAEMORRHOIDS

time Frame

From first dose of nilotinib through up to approximately 11 years of study participation, including the NTCS phase (up to 52 weeks), TFR phase (up to 528 weeks), and NTRI phases (up to 500 weeks)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice