NCT02554812 · ADVERSE EVENTS

Adverse events

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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: Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.
Other-event reporting threshold: 5%

The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. For AE and SAE safety analysis set was analyzed. Safety analysis set includes all participants who received at least 1 dose of study drug. For All-Cause Mortality full analysis set was analyzed. Full analysis set includes all randomized participants in the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.	11 / 29	29 / 29	18 / 29
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	12 / 27	27 / 27	19 / 28
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	13 / 29	28 / 29	20 / 29
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	9 / 28	28 / 28	19 / 28
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	16 / 35	33 / 35	25 / 35
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	4 / 21	20 / 21	12 / 21
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	4 / 10	10 / 10	6 / 10
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	8 / 21	21 / 21	14 / 21
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.	4 / 11	11 / 11	7 / 11
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.	1 / 11	10 / 11	6 / 11
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.	3 / 12	12 / 12	7 / 12
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.	4 / 12	12 / 12	6 / 12
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.	1 / 8	8 / 8	6 / 8
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.	3 / 14	14 / 14	8 / 14
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.	10 / 25	25 / 25	21 / 25
Combination C Phase 1b: PD 0360324 50 mg + Avelumab During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	4 / 10	9 / 10	5 / 10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	3 / 8	8 / 8	4 / 8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.	4 / 6	6 / 6	4 / 6
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	2 / 12	12 / 12	9 / 12
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	3 / 12	11 / 12	7 / 12
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	4 / 12	12 / 12	7 / 12
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	5 / 12	11 / 12	8 / 12
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	4 / 12	12 / 12	10 / 12
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.	5 / 11	11 / 11	7 / 11
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.	2 / 6	5 / 6	4 / 6
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.	4 / 7	7 / 7	5 / 7
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.	4 / 7	7 / 7	7 / 7

Group identifiers: EG000: Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab · EG001: Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab · EG002: Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab · EG003: Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab · EG004: Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab · EG005: Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab · EG006: Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab · EG007: Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab · EG008: Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab · EG009: Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab · EG010: Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab · EG011: Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab · EG012: Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab · EG013: Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab · EG014: Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab · EG015: Combination C Phase 1b: PD 0360324 50 mg + Avelumab · EG016: Combination C Phase 1b: PD 0360324 100 mg + Avelumab · EG017: Combination C Phase 1b: PD 0360324 150 mg + Avelumab · EG018: Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab · EG019: Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab · EG020: Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab · EG021: Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab · EG022: Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab · EG023: Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab · EG024: Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab · EG025: Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg · EG026: Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Cardiac tamponade
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Nausea

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
4
num At Risk
27
group Id
EG002
num Affected
1
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
6
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
3
num At Risk
11
group Id
EG010
num Affected
1
num At Risk
12
group Id
EG011
num Affected
3
num At Risk
12
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Increased tendency to bruise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Iron deficiency anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
2
num At Risk
29
group Id
EG003
num Affected
2
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
1
num At Risk
12
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
1
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
2
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Sinus tachycardia

Complete source fields

description

event Groups

deaths Num Affected
18
deaths Num At Risk
29
description
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
id
EG000
other Num Affected
29
other Num At Risk
29
serious Num Affected
11
serious Num At Risk
29
title
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
deaths Num Affected
19
deaths Num At Risk
28
description
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG001
other Num Affected
27
other Num At Risk
27
serious Num Affected
12
serious Num At Risk
27
title
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
deaths Num Affected
20
deaths Num At Risk
29
description
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG002
other Num Affected
28
other Num At Risk
29
serious Num Affected
13
serious Num At Risk
29
title
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
deaths Num Affected
19
deaths Num At Risk
28
description
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG003
other Num Affected
28
other Num At Risk
28
serious Num Affected
9
serious Num At Risk
28
title
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
deaths Num Affected
25
deaths Num At Risk
35
description
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG004
other Num Affected
33
other Num At Risk
35
serious Num Affected
16
serious Num At Risk
35
title
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
deaths Num Affected
12
deaths Num At Risk
21
description
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG005
other Num Affected
20
other Num At Risk
21
serious Num Affected
4
serious Num At Risk
21
title
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
deaths Num Affected
6
deaths Num At Risk
10
description
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
deaths Num Affected
14
deaths Num At Risk
21
description
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
EG007
other Num Affected
21
other Num At Risk
21
serious Num Affected
8
serious Num At Risk
21
title
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
deaths Num Affected
7
deaths Num At Risk
11
description
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
id
EG008
other Num Affected
11
other Num At Risk
11
serious Num Affected
4
serious Num At Risk
11
title
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
deaths Num Affected
6
deaths Num At Risk
11
description
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
id
EG009
other Num Affected
10
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
deaths Num Affected
7
deaths Num At Risk
12
description
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
id
EG010
other Num Affected
12
other Num At Risk
12
serious Num Affected
3
serious Num At Risk
12
title
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
deaths Num Affected
6
deaths Num At Risk
12
description
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
id
EG011
other Num Affected
12
other Num At Risk
12
serious Num Affected
4
serious Num At Risk
12
title
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
4
num At Risk
27
group Id
EG002
num Affected
1
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
6
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
3
num At Risk
11
group Id
EG010
num Affected
1
num At Risk
12
group Id
EG011
num Affected
3
num At Risk
12
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Increased tendency to bruise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Iron deficiency anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
2
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
2
num At Risk
29
group Id
EG003
num Affected
2
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
1
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
1
num At Risk
12
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
1
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
2
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Sinus tachycardia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
1
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Cardiac tamponade
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
1
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
1
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
0
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.0
stats
group Id
EG000
num Affected
0
num At Risk
29
group Id
EG001
num Affected
1
num At Risk
27
group Id
EG002
num Affected
0
num At Risk
29
group Id
EG003
num Affected
0
num At Risk
28
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
21
group Id
EG008
num Affected
0
num At Risk
11
group Id
EG009
num Affected
0
num At Risk
11
group Id
EG010
num Affected
0
num At Risk
12
group Id
EG011
num Affected
0
num At Risk
12
term
Nausea

time Frame

Baseline up to 30 days post last dose (upto a maximum of 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality was from randomization until death, assessed up to 7.3 years.

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Preserved source evidence · Not medical advice