NCT05061537 · ADVERSE EVENTS
Adverse events
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
- All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months).
- Other-event reporting threshold
- 5%
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | 0 / 3 | 3 / 3 | 0 / 3 |
| Part 1A PF-07263689 6*10^8 PFU | 1 / 4 | 4 / 4 | 1 / 4 |
| Part 1A PF-07263689 20*10^8PFU | 2 / 6 | 6 / 6 | 0 / 6 |
| Part 1B: PF-07263689 + Sasanlimab | 0 / 0 | 0 / 0 | 0 / 0 |
| Part 2: PF-07263689 + Sasanlimab | 0 / 0 | 0 / 0 | 0 / 0 |
Serious adverse events
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anal haemorrhage
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Nausea
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Vomiting
Other reported adverse events
- 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
- 2
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac 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
- 4
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Tachycardia
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain upper
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anal haemorrhage
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Ascites
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Haematochezia
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Nausea
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Oral pain
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Asthenia
Complete source fields
- description
- Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Adverse event reported only for Part 1a. Since there was no enrolment for Part 1b and 2, no safety data collected and reported.
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- Part 1A PF-07263689 2*10^8 PFU
- deaths Num Affected
- 1
- deaths Num At Risk
- 4
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- EG001
- other Num Affected
- 4
- other Num At Risk
- 4
- serious Num Affected
- 1
- serious Num At Risk
- 4
- title
- Part 1A PF-07263689 6*10^8 PFU
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study.
- id
- EG002
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 2
- serious Num At Risk
- 6
- title
- Part 1A PF-07263689 20*10^8PFU
- deaths Num Affected
- 0
- deaths Num At Risk
- 0
- description
- Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab.
- id
- EG003
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Part 1B: PF-07263689 + Sasanlimab
- deaths Num Affected
- 0
- deaths Num At Risk
- 0
- description
- Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B.
- id
- EG004
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Part 2: PF-07263689 + Sasanlimab
- frequency Threshold
- 5
- other Events
- 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
- 2
- num At Risk
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac 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
- 4
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Tachycardia
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain upper
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anal haemorrhage
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Ascites
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Haematochezia
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Nausea
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Oral pain
- 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
- 4
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Asthenia
- serious Events
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Abdominal pain
- 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
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Anal haemorrhage
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Nausea
- 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
- 4
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 0
- term
- Vomiting
- time Frame
- All-cause mortality: From first dose of study treatment until death, withdrawal of consent, or end of the study (up to maximum follow-up of 10.45 months); SAEs and non-SAEs: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months).
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Preserved source evidence · Not medical advice
Triangle