NCT02358031 · ADVERSE EVENTS

Adverse events

A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) · Source last updated 2025-07-18

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 approximately 98 months
Other-event reporting threshold: 5%

All-Cause Mortality (ACM): all randomized participants. AEs: all randomized participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Per protocol, ACM and AEs were collected and reported separately for pembrolizumab second course.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab Monotherapy (First Course) Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).	123 / 300	265 / 300	260 / 301
Pembrolizumab + Chemotherapy (First Course) Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).	165 / 276	266 / 276	242 / 281
Cetuximab + Chemotherapy (Control) Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).	142 / 287	278 / 287	282 / 300
Pembrolizumab Monotherapy (Second Course) Qualified participants who received the first course of pembrolizumab monotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).	1 / 8	6 / 8	5 / 8
Pembrolizumab + Chemotherapy (Second Course) Qualified participants who received the first course of pembrolizumab in combination with chemotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).	2 / 6	6 / 6	5 / 6

Group identifiers: EG000: Pembrolizumab Monotherapy (First Course) · EG001: Pembrolizumab + Chemotherapy (First Course) · EG002: Cetuximab + Chemotherapy (Control) · EG003: Pembrolizumab Monotherapy (Second Course) · EG004: Pembrolizumab + Chemotherapy (Second Course)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
14
num At Risk
276
num Events
17
group Id
EG002
num Affected
9
num At Risk
287
num Events
11
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
2
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Anaemia of chronic disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
17
num At Risk
276
num Events
17
group Id
EG002
num Affected
15
num At Risk
287
num Events
16
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
6
num At Risk
276
num Events
6
group Id
EG002
num Affected
4
num At Risk
287
num Events
6
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
6
num At Risk
276
num Events
6
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Angina pectoris

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 26.0
stats
group Id
EG000
num Affected
61
num At Risk
300
num Events
82
group Id
EG001
num Affected
153
num At Risk
276
num Events
210
group Id
EG002
num Affected
128
num At Risk
287
num Events
251
group Id
EG003
num Affected
2
num At Risk
8
num Events
6
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
300
num Events
5
group Id
EG001
num Affected
37
num At Risk
276
num Events
57
group Id
EG002
num Affected
41
num At Risk
287
num Events
87
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
10
group Id
EG001
num Affected
9
num At Risk
276
num Events
20
group Id
EG002
num Affected
16
num At Risk
287
num Events
58
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
300
num Events
14
group Id
EG001
num Affected
90
num At Risk
276
num Events
135
group Id
EG002
num Affected
93
num At Risk
287
num Events
194
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
300
num Events
6
group Id
EG001
num Affected
74
num At Risk
276
num Events
111
group Id
EG002
num Affected
71
num At Risk
287
num Events
148
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
17
num At Risk
276
num Events
17
group Id
EG002
num Affected
19
num At Risk
287
num Events
21
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
55
num At Risk
300
num Events
57
group Id
EG001
num Affected
45
num At Risk
276
num Events
48
group Id
EG002
num Affected
18
num At Risk
287
num Events
22
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
7
group Id
EG001
num Affected
5
num At Risk
276
num Events
5
group Id
EG002
num Affected
6
num At Risk
287
num Events
10
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
300
num Events
2
group Id
EG001
num Affected
9
num At Risk
276
num Events
11
group Id
EG002
num Affected
19
num At Risk
287
num Events
27
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
7
group Id
EG001
num Affected
11
num At Risk
276
num Events
13
group Id
EG002
num Affected
19
num At Risk
287
num Events
24
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Apical granuloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
59
num At Risk
300
num Events
62
group Id
EG001
num Affected
101
num At Risk
276
num Events
145
group Id
EG002
num Affected
95
num At Risk
287
num Events
134
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
3
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
260
deaths Num At Risk
301
description
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).
id
EG000
other Num Affected
265
other Num At Risk
300
serious Num Affected
123
serious Num At Risk
300
title
Pembrolizumab Monotherapy (First Course)
deaths Num Affected
242
deaths Num At Risk
281
description
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
id
EG001
other Num Affected
266
other Num At Risk
276
serious Num Affected
165
serious Num At Risk
276
title
Pembrolizumab + Chemotherapy (First Course)
deaths Num Affected
282
deaths Num At Risk
300
description
Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
id
EG002
other Num Affected
278
other Num At Risk
287
serious Num Affected
142
serious Num At Risk
287
title
Cetuximab + Chemotherapy (Control)
deaths Num Affected
5
deaths Num At Risk
8
description
Qualified participants who received the first course of pembrolizumab monotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
id
EG003
other Num Affected
6
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Pembrolizumab Monotherapy (Second Course)
deaths Num Affected
5
deaths Num At Risk
6
description
Qualified participants who received the first course of pembrolizumab in combination with chemotherapy but continued to experience disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Pembrolizumab + Chemotherapy (Second Course)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
61
num At Risk
300
num Events
82
group Id
EG001
num Affected
153
num At Risk
276
num Events
210
group Id
EG002
num Affected
128
num At Risk
287
num Events
251
group Id
EG003
num Affected
2
num At Risk
8
num Events
6
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
300
num Events
5
group Id
EG001
num Affected
37
num At Risk
276
num Events
57
group Id
EG002
num Affected
41
num At Risk
287
num Events
87
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
10
group Id
EG001
num Affected
9
num At Risk
276
num Events
20
group Id
EG002
num Affected
16
num At Risk
287
num Events
58
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
300
num Events
14
group Id
EG001
num Affected
90
num At Risk
276
num Events
135
group Id
EG002
num Affected
93
num At Risk
287
num Events
194
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
300
num Events
6
group Id
EG001
num Affected
74
num At Risk
276
num Events
111
group Id
EG002
num Affected
71
num At Risk
287
num Events
148
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
17
num At Risk
276
num Events
17
group Id
EG002
num Affected
19
num At Risk
287
num Events
21
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
55
num At Risk
300
num Events
57
group Id
EG001
num Affected
45
num At Risk
276
num Events
48
group Id
EG002
num Affected
18
num At Risk
287
num Events
22
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
7
group Id
EG001
num Affected
5
num At Risk
276
num Events
5
group Id
EG002
num Affected
6
num At Risk
287
num Events
10
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
300
num Events
2
group Id
EG001
num Affected
9
num At Risk
276
num Events
11
group Id
EG002
num Affected
19
num At Risk
287
num Events
27
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
7
num At Risk
300
num Events
7
group Id
EG001
num Affected
11
num At Risk
276
num Events
13
group Id
EG002
num Affected
19
num At Risk
287
num Events
24
group Id
EG003
num Affected
1
num At Risk
8
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
term
Apical granuloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
59
num At Risk
300
num Events
62
group Id
EG001
num Affected
101
num At Risk
276
num Events
145
group Id
EG002
num Affected
95
num At Risk
287
num Events
134
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
3
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
14
num At Risk
276
num Events
17
group Id
EG002
num Affected
9
num At Risk
287
num Events
11
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
2
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Anaemia of chronic disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
17
num At Risk
276
num Events
17
group Id
EG002
num Affected
15
num At Risk
287
num Events
16
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
6
num At Risk
276
num Events
6
group Id
EG002
num Affected
4
num At Risk
287
num Events
6
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
6
num At Risk
276
num Events
6
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
300
num Events
0
group Id
EG001
num Affected
0
num At Risk
276
num Events
0
group Id
EG002
num Affected
1
num At Risk
287
num Events
1
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
300
num Events
1
group Id
EG001
num Affected
1
num At Risk
276
num Events
1
group Id
EG002
num Affected
0
num At Risk
287
num Events
0
group Id
EG003
num Affected
0
num At Risk
8
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
term
Angina pectoris

time Frame

Up to approximately 98 months

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

Preserved source evidence · Not medical advice