NCT02663518 · ADVERSE EVENTS

Adverse events

A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors · Source last updated 2024-05-10

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: Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)
Other-event reporting threshold: 5%

Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis population included all the participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	1 / 3	2 / 3	0 / 3
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	0 / 3	3 / 3	1 / 3
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	1 / 7	7 / 7	1 / 7
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	2 / 5	5 / 5	1 / 5
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	43 / 107	100 / 107	52 / 107
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.	2 / 11	11 / 11	0 / 11
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.	13 / 40	34 / 40	27 / 40
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	15 / 42	36 / 42	16 / 42
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	1 / 3	3 / 3	0 / 3
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	1 / 3	2 / 3	0 / 3
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	2 / 6	6 / 6	2 / 6
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	0 / 3	3 / 3	0 / 3
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	3 / 12	12 / 12	5 / 12
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.	3 / 4	4 / 4	1 / 4

Group identifiers: EG000: Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg · EG001: Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg · EG002: Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg · EG003: Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg · EG004: Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy · EG005: Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination · EG006: Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination · EG007: Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy · EG008: Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg · EG009: Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg · EG010: Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg · EG011: Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg · EG012: Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg · EG013: Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 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
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
4
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
3
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
3
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
2
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
4
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pneumonia Fungal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Abdominal Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Bronchitis Viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Campylobacter Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Cytomegalovirus Infection Reactivation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Hepatic Infection

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
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
39
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
18
num At Risk
40
group Id
EG007
num Affected
13
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
28
num At Risk
107
group Id
EG005
num Affected
5
num At Risk
11
group Id
EG006
num Affected
5
num At Risk
40
group Id
EG007
num Affected
16
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
23
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
10
num At Risk
40
group Id
EG007
num Affected
10
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
9
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
5
num At Risk
40
group Id
EG007
num Affected
4
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Oedema Peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
5
group Id
EG004
num Affected
44
num At Risk
107
group Id
EG005
num Affected
5
num At Risk
11
group Id
EG006
num Affected
17
num At Risk
40
group Id
EG007
num Affected
14
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
4
num At Risk
6
group Id
EG011
num Affected
2
num At Risk
3
term
Infusion Related Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
11
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
40
group Id
EG007
num Affected
5
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
28
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
6
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
group Id
EG011
num Affected
1
num At Risk
3
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
3
num At Risk
5
group Id
EG004
num Affected
23
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
5
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
20
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
7
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
1
num At Risk
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
11
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
6
num At Risk
40
group Id
EG007
num Affected
2
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
7
num At Risk
107
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
31
num At Risk
107
group Id
EG005
num Affected
4
num At Risk
11
group Id
EG006
num Affected
10
num At Risk
40
group Id
EG007
num Affected
8
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Anaemia

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 milligram per kilogram (mg/kg) infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG000
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
deaths Num Affected
1
deaths Num At Risk
3
description
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
deaths Num Affected
1
deaths Num At Risk
7
description
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
deaths Num Affected
1
deaths Num At Risk
5
description
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG003
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
deaths Num Affected
52
deaths Num At Risk
107
description
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG004
other Num Affected
100
other Num At Risk
107
serious Num Affected
43
serious Num At Risk
107
title
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
deaths Num Affected
0
deaths Num At Risk
11
description
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL.If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
id
EG005
other Num Affected
11
other Num At Risk
11
serious Num Affected
2
serious Num At Risk
11
title
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
deaths Num Affected
27
deaths Num At Risk
40
description
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
id
EG006
other Num Affected
34
other Num At Risk
40
serious Num Affected
13
serious Num At Risk
40
title
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
deaths Num Affected
16
deaths Num At Risk
42
description
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG007
other Num Affected
36
other Num At Risk
42
serious Num Affected
15
serious Num At Risk
42
title
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG009
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
deaths Num Affected
2
deaths Num At Risk
6
description
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG010
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
id
EG011
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
39
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
18
num At Risk
40
group Id
EG007
num Affected
13
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
28
num At Risk
107
group Id
EG005
num Affected
5
num At Risk
11
group Id
EG006
num Affected
5
num At Risk
40
group Id
EG007
num Affected
16
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
23
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
10
num At Risk
40
group Id
EG007
num Affected
10
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
9
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
5
num At Risk
40
group Id
EG007
num Affected
4
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Oedema Peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
5
group Id
EG004
num Affected
44
num At Risk
107
group Id
EG005
num Affected
5
num At Risk
11
group Id
EG006
num Affected
17
num At Risk
40
group Id
EG007
num Affected
14
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
4
num At Risk
6
group Id
EG011
num Affected
2
num At Risk
3
term
Infusion Related Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
11
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
40
group Id
EG007
num Affected
5
num At Risk
42
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
28
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
6
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
6
group Id
EG011
num Affected
1
num At Risk
3
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
7
group Id
EG003
num Affected
3
num At Risk
5
group Id
EG004
num Affected
23
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
8
num At Risk
40
group Id
EG007
num Affected
5
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
20
num At Risk
107
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
7
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
1
num At Risk
3
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
5
group Id
EG004
num Affected
11
num At Risk
107
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
6
num At Risk
40
group Id
EG007
num Affected
2
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
7
num At Risk
107
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
31
num At Risk
107
group Id
EG005
num Affected
4
num At Risk
11
group Id
EG006
num Affected
10
num At Risk
40
group Id
EG007
num Affected
8
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Anaemia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
4
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
3
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
3
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
2
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
4
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
40
group Id
EG007
num Affected
1
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Pneumonia Fungal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Abdominal Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Bronchitis Viral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Campylobacter Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Covid-19 Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Cytomegalovirus Infection Reactivation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v25.1
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
107
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
40
group Id
EG007
num Affected
0
num At Risk
42
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
6
group Id
EG011
num Affected
0
num At Risk
3
term
Hepatic Infection

time Frame

Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for: Part 1 was 414 days, Part 2 was 1793 days, Part 3 was 938 days, and Part 4 was 667 days)

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

Preserved source evidence · Not medical advice